ViolenceNCT02506088
Preventing Sexual Aggression Among High School Boys
A study testing Your Voice Your View in people with Violence, run by Lifespan at 1 site in United States.
Trial summary
The present research creates a partnership between researchers and a community agency to evaluate whether a sexual assault prevention program for high school students reduces perpetration of sexual violence among high school boys. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- Your Voice Your View
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,910 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescents at Rhode Island high schools will be eligible for enrollment according to the following criteria: 1) adolescent assent given; 3) passive consent of a parent/legal guardian is given. Teachers will be eligible to participate in educator assessments if consent is given.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02904
About this study
The present research creates a partnership between researchers and a community agency to evaluate whether a sexual assault prevention program for high school students reduces perpetration of sexual violence among high school boys.
Read the detailed description
The present research advances the science of sexual assault prevention by creating a mutually beneficial partnership between well-established sexual assault prevention researchers and a CDC Rape Prevention and Education Program (RPE)-funded community agency to conduct a rigorous experimental evaluation of universal primary prevention programming designed to reduce sexual aggression among high school boys. The present research tests multi-session prevention programming that targets change at multiple levels of the social ecology (i.e., individual-, peer- and community-level) through social norms theory and bystander education. Specifically, the present research evaluates Your Voice Your View. Your Voice Your View was developed and is currently administered in Rhode Island High Schools by the CDC RPE-funded agency Day One of Rhode Island. The program will be tested in a group randomized cluster trial among 10th graders at 30 high schools, with the aim of reducing perpetration of sexual aggression among high school boys.
Specifically, this research will conduct a randomized controlled trial with a sample of 10th grade students to demonstrate efficacy of the intervention in reducing rates of sexual aggression among high school boys, rates of dating violence involvement, and related risk and protective factors over a 2- and 6-month follow-up in comparison to a wait-list control group. Thirty schools will be matched on demographic characteristics (i.e., % receiving subsidized lunch, racial/ethnic minority enrollment) and randomized to receive Your Voice Your View or to the wait-list control group.
- Conditions
- Violence
- Being tested
- Your Voice Your View
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Your Voice Your ViewBehavioural
Session 1 of the intervention involves background information, an introduction to social norms, and bystander intervention skills training. Session 2 of the intervention establishes conditions for consent, types of abusive behavior and identifying abuse. Session 3 of the intervention addresses risk reduction strategies for girls. Session 3 of the intervention addresses false accusations, masculinity, and additional practice on identifying conditions for consent for boys. Session 4 of the intervention includes active practice of bystander intervention skills.
| Study group | Role | What they receive |
|---|---|---|
| Your Voice Your View | Experimental | Participants in schools assigned to the treatment group will engage in a four session intervention aimed at prevention of sexual violence. Your Voice Your View is grounded in social norms theory and bystander intervention training. The intervention also includes a social norms marketing campaign. Receives: Behavioral: Your Voice Your View |
| Wait List Control Group | No intervention | Participants in schools assigned to the wait list control group will complete survey assessments at the same schedule as schools assigned to the treatment group. Schools will have the option to implement Your Voice Your View following completion of the 6-month survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perpetration of Sexual Violence Survey
Measured: up to 6-months
Secondary outcomes (3)
Rate of Dating Violence Perpetration
Measured: up to 6 months
Rape Myth Acceptance Survey
Measured: up to 6 months
Bystander Intervention Skills Survey
Composite measure: Increase Positive Bystander Behavior, Decrease Barriers to Intervening, Increase Likelihood of Intervening
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Orchowski Ph.D., Lifespan
- Investigators
- Lindsay M. Orchowski, Ph.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506088
- Sponsor's protocol ID
- 1U01CE002531
- Status last verified
- Oct 2018
- First submitted
- 21 Jul 2015
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Sexual Aggression Among High School Boys
- ClinicalTrials.gov ID
- NCT02506088
- Acronym / sponsor ID
- 1U01CE002531
- Conditions
- Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,910 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present research creates a partnership between researchers and a community agency to evaluate whether a sexual assault prevention program for high school students reduces perpetration of sexual violence among high school boys.
Detailed description
The present research advances the science of sexual assault prevention by creating a mutually beneficial partnership between well-established sexual assault prevention researchers and a CDC Rape Prevention and Education Program (RPE)-funded community agency to conduct a rigorous experimental evaluation of universal primary prevention programming designed to reduce sexual aggression among high school boys. The present research tests multi-session prevention programming that targets change at multiple levels of the social ecology (i.e., individual-, peer- and community-level) through social norms theory and bystander education. Specifically, the present research evaluates Your Voice Your View. Your Voice Your View was developed and is currently administered in Rhode Island High Schools by the CDC RPE-funded agency Day One of Rhode Island. The program will be tested in a group randomized cluster trial among 10th graders at 30 high schools, with the aim of reducing perpetration of sexual aggression among high school boys.
Specifically, this research will conduct a randomized controlled trial with a sample of 10th grade students to demonstrate efficacy of the intervention in reducing rates of sexual aggression among high school boys, rates of dating violence involvement, and related risk and protective factors over a 2- and 6-month follow-up in comparison to a wait-list control group. Thirty schools will be matched on demographic characteristics (i.e., % receiving subsidized lunch, racial/ethnic minority enrollment) and randomized to receive Your Voice Your View or to the wait-list control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Your Voice Your View | Experimental | Behavioral: Your Voice Your ViewParticipants in schools assigned to the treatment group will engage in a four session intervention aimed at prevention of sexual violence. Your Voice Your View is grounded in social norms theory and bystander intervention training. The intervention also includes a social norms marketing campaign. |
| Wait List Control Group | No intervention | –Participants in schools assigned to the wait list control group will complete survey assessments at the same schedule as schools assigned to the treatment group. Schools will have the option to implement Your Voice Your View following completion of the 6-month survey. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adolescents at Rhode Island high schools will be eligible for enrollment according to the following criteria: 1) adolescent assent given; 3) passive consent of a parent/legal guardian is given. Teachers will be eligible to participate in educator assessments if consent is given.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Your Voice Your ViewSession 1 of the intervention involves background information, an introduction to social norms, and bystander intervention skills training. Session 2 of the intervention establishes conditions for consent, types of abusive behavior and identifying abuse. Session 3 of the intervention addresses risk reduction strategies for girls. Session 3 of the intervention addresses false accusations, masculinity, and additional practice on identifying conditions for consent for boys. Session 4 of the intervention includes active practice of bystander intervention skills. | Behavioural | Your Voice Your View |
Primary outcome
Perpetration of Sexual Violence Survey
Time frame: up to 6-months
3 secondary outcomes
Rate of Dating Violence Perpetration
Time frame: up to 6 months
Rape Myth Acceptance Survey
Time frame: up to 6 months
Bystander Intervention Skills Survey
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay M. Orchowski, Ph.D. principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Your Voice Your View in people with Violence, run by Lifespan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perpetration of Sexual Violence Survey (time frame: up to 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.